HypersensitivityPhase 3NCT07257042
Oothpaste Containing 8% Arginine Compared to Colgate Cavity Protection Toothpaste in Reducing Dentinal Hypersensitivity
A Phase 3 study testing Toothpaste containing 8% Arginine and Colgate Cavity Protection Toothpaste in people with Hypersensitivity, run by Colgate Palmolive at 1 site in United States.
Trial summary
The objective of this study is to assess clinical efficacy of a toothpaste containing 8% arginine (Colgate-Palmolive Company, New York, NY, USA) to provide dental hypersensitivity relief (tactile and air blast) in comparison to Colgate Cavity Protection Toothpaste (Colgate-Palmolive Company, New York, NY, USA) over an… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- Toothpaste containing 8% Arginine and Colgate Cavity Protection Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 4 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects, ages 18-70, inclusive.
- Availability for the eight-week duration of the study.
- Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
- Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50 gms. of force.
- Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
- Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study.
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- Good general health with no known allergies to products being tested.
- Use of a non-desensitizing dentifrice for three months prior to entry into the study.
- Signed Informed Consent Form
Who cannot join
- Gross oral pathology, chronic disease, or history of allergy to test products.
- Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
- Sensitive teeth with a mobility greater than one.
- Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
- Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics.
- Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
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- Current participation in any other clinical study.
- Pregnant or lactating subjects.
- Allergies to oral care products, personal care consumer products, or their ingredients.
- Medical condition which prohibits not eating/drinking for 4 hours.
- Use in the past of the two test dentifrices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Investigation of a Toothpaste Containing 8% Arginine Compared to Colgate Cavity Protection Toothpaste in Reducing Dentinal Hypersensitivity - an Eight-week Clinical Study in the US
The objective of this study is to assess clinical efficacy of a toothpaste containing 8% arginine (Colgate-Palmolive Company, New York, NY, USA) to provide dental hypersensitivity relief (tactile and air blast) in comparison to Colgate Cavity Protection Toothpaste (Colgate-Palmolive Company, New York, NY, USA) over an eight-week period.
- Conditions
- Hypersensitivity
- Being tested
- Toothpaste containing 8% Arginine, Colgate Cavity Protection Toothpaste
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste containing 8% ArginineDrug
Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste
Colgate Cavity Protection ToothpasteDrug
Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Test 1 toothpaste | Experimental | subjects will brush with assigned toothpaste morning \& night Receives: Drug: Toothpaste containing 8% Arginine |
| Control toothpaste | Active comparator | subjects will brush with assigned toothpaste morning \& night Receives: Drug: Colgate Cavity Protection Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tactile stimulation with a Yeaple Probe. treatment Tactile and Air Blast Hypersensitivity scores. The mean Tactile and Air Blast Hypersensitivity will be computed and summarized
Sensitivity will be defined by a score in the range of 10-50 gms. of force
Measured: Baseline 4 week & 8 week
Schiff Cold Air Sensitivity Scale
Sensitivity will be defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale
Measured: Baseline 4 week & 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start14 Jul 2025
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yiming LI, DDS, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257042
- Sponsor's protocol ID
- CRO-2025-06-SEN-TOM-ARG-YPZ
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Investigation of a Toothpaste Containing 8% Arginine Compared to Colgate Cavity Protection Toothpaste in Reducing Dentinal Hypersensitivity - an Eight-week Clinical Study in the US
- ClinicalTrials.gov ID
- NCT07257042
- Acronym / sponsor ID
- CRO-2025-06-SEN-TOM-ARG-YPZ
- Conditions
- Hypersensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess clinical efficacy of a toothpaste containing 8% arginine (Colgate-Palmolive Company, New York, NY, USA) to provide dental hypersensitivity relief (tactile and air blast) in comparison to Colgate Cavity Protection Toothpaste (Colgate-Palmolive Company, New York, NY, USA) over an eight-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test 1 toothpaste | Experimental | Drug: Toothpaste containing 8% Argininesubjects will brush with assigned toothpaste morning \& night |
| Control toothpaste | Active comparator | Drug: Colgate Cavity Protection Toothpastesubjects will brush with assigned toothpaste morning \& night |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects, ages 18-70, inclusive.
- Availability for the eight-week duration of the study.
- Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
- Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50 gms. of force.
- Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
Key exclusion criteria (11 listed)
- Gross oral pathology, chronic disease, or history of allergy to test products.
- Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
- Sensitive teeth with a mobility greater than one.
- Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
- Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste containing 8% ArginineBrush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste | Drug | Test 1 toothpaste |
| Colgate Cavity Protection ToothpasteBrush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste | Drug | Control toothpaste |
Primary outcome
Tactile stimulation with a Yeaple Probe. treatment Tactile and Air Blast Hypersensitivity scores. The mean Tactile and Air Blast Hypersensitivity will be computed and summarized
Time frame: Baseline 4 week & 8 week
Sensitivity will be defined by a score in the range of 10-50 gms. of force
Schiff Cold Air Sensitivity Scale
Time frame: Baseline 4 week & 8 week
Sensitivity will be defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiming LI, DDS, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toothpaste containing 8% Arginine and Colgate Cavity Protection Toothpaste in people with Hypersensitivity, run by Colgate Palmolive at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactile stimulation with a Yeaple Probe. treatment Tactile and Air Blast Hypersensitivity scores. The mean Tactile and Air Blast Hypersensitivity will be computed and summarized (time frame: Baseline 4 week & 8 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.